[Federal Register: October 5, 2001 (Volume 66, Number 194)]
[Page 51052-51053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Nonclinical Studies Subcommittee of the Advisory Committee for 
Pharmaceutical Science; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Nonclinical Studies Subcommittee of the Advisory 
Committee for Pharmaceutical Science.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 13, 2001, from 
8 a.m. to 12:15 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee conference room 1066, 5630 Fishers Lane, Rockville, MD.
    Contact: Kimberly Topper, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-
7001, e-mail: TopperK@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12539. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The subcommittee will discuss the activities of the two 
expert working groups requested by this subcommittee: The working group 
on biomarkers of cardiac tissue injury and the working group on 
biomarkers of vasculitis (vascular damage). Representatives from each 
working group will report their progress and plans, and the 
subcommittee will discuss these activities and provide feedback to the 
working groups. Administrative oversight of the subcommittee will be 
discussed, including the possibility of integration with the Scientific 
Advisory Board of the FDA National Center for Toxicological Research.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by November 6, 
2001. Oral

[[Page 51053]]

presentations from the public will be scheduled between approximately 
11 a.m. and 12 noon. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before November 6, 2001, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 28, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-24997 Filed 10-4-01; 8:45 am]